SS Innovations Plans FDA Submission for Advanced Surgical System
SS Innovations to Submit Application for Surgical Robotic System
FORT LAUDERDALE, Fla. — SS Innovations International, Inc. (Nasdaq: SSII), a leader in surgical robotic technologies, has unveiled plans to submit a De Novo Classification Request to the U.S. Food and Drug Administration for its innovative SSi Mantra 3 surgical robotic system. This submission is scheduled for July 2025 and represents a significant milestone in the Company’s mission to make robotic surgery more accessible and cost-effective for a wider audience.
FDA Approval Process
Obtaining FDA approval for the SSi Mantra 3 would allow for its market introduction across the United States, although the submission does not guarantee approval. The regulatory process is rigorous, requiring comprehensive data demonstrating the system's safety and efficacy.
Growth and Expansion of SSi Mantra Systems
Since launching its systems in late 2022, SS Innovations has experienced remarkable growth, having installed 80 SSi Mantra systems in 75 hospitals across different healthcare facilities. With over 3,800 surgeries performed — including more than 200 cardiac procedures — these robotic systems are proving their worth in real-world applications.
SSi Mantra 3’s Capabilities
The recently launched SSi Mantra 3 has already been deployed in 37 hospitals, contributing to more than 750 surgeries in various specialties, with impressive outcomes — no recorded device-related complications or injuries. This remarkable achievement demonstrates the reliability and effectiveness of the SSi Mantra 3, as validated by a reputable contract research organization.
Multispecialty Indications for Broader Applications
The upcoming application aims to include multispecialty indications, allowing the SSi Mantra 3 to serve in diverse medical fields such as urology, gynecology, general surgery, and both thoracic and cardiac surgery. This expansion signifies SS Innovations' commitment to versatility and comprehensive surgical applications.
Leadership Insights
Dr. Sudhir Srivastava, who serves as the Chairman of the Board and CEO, expressed enthusiasm over the Company's global reach, already functioning in six countries. He emphasized the importance of the planned De Novo application as a step toward further establishing SS Innovations in the U.S. market. Furthermore, the Company is concurrently working towards achieving European Union CE Mark approval for the SSi Mantra system, reflecting their strategic focus on international expansion and success.
About SS Innovations
SS Innovations International, Inc. (Nasdaq: SSII) is dedicated to developing surgical robotic technologies that aim to provide an accessible healthcare solution. The SSi Mantra system showcases advanced capabilities, featuring modular robotic arms, ergonomic controls, and cutting-edge imaging technology. These installations are tailored to various surgical needs, making it an integral tool in medical facilities.
Technical Features of the SSi Mantra
The SSi Mantra Surgical Robotic System is not just another robotic system; it incorporates a unique modular design that allows flexibility and adaptability in surgical procedures. With features like 3 to 5 robotic arms, a large 3D 4K monitor, and a real-time imaging interface, it provides both patients and medical teams with enhanced surgical precision and safety. It addresses a wide range of surgical specialties, including cardiac surgery, and has been validated through numerous clinical applications.
Frequently Asked Questions
What is the SSi Mantra 3 surgical robotic system?
The SSi Mantra 3 is an advanced surgical robotic system developed by SS Innovations, designed to perform a variety of surgical procedures safely and effectively.
When will SS Innovations submit the De Novo application?
The Company is planning to submit the De Novo Classification Request to the FDA in July 2025.
What specialties can the SSi Mantra 3 serve?
The system is designed for multispecialty use, including applications in urology, gynecology, general surgery, and cardiac surgery.
How many systems has SS Innovations installed so far?
The Company has installed 80 SSi Mantra systems across 75 hospitals since launching its sales.
What does FDA approval mean for SS Innovations?
FDA approval would allow the SSi Mantra 3 to be marketed in the United States, potentially increasing access to innovative surgical technology.
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